Soleus Powered Wheelchair Model FAD-2
by Soleus Champ International Co., Ltd.
510(k) K043511
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043511 | Date14 Mar 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Soleus Powered Wheelchair Model FAD-2 is a battery-operated mobility device classified as a Powered Wheelchair. It is designed to provide independent mobility for users indoors and outdoors, featuring a four-wheeled base and a seat for seating support. The device is operated via hand controls mounted on a steering column, enabling precise maneuverability for the rider.
This wheelchair is intended for single-use or reusable applications in clinical and home settings, depending on usage frequency and maintenance protocols. It is equipped with an onboard battery charger for convenience and can be disassembled for transport. The device adheres to FDA clearance under 510(k) classification, with regulatory compliance under the regulation number 890.3860. No specific sterility or MRI safety information is provided in the data.
Questions
AI-generated answers, 1 Oct 2026
What is the Soleus FAD-2 Powered Wheelchair designed for?
The Soleus FAD-2 Powered Wheelchair is designed to provide independent mobility for users in both clinical and home settings. It is specifically engineered for indoor and outdoor use, allowing users to navigate various environments with ease. The device’s four-wheeled base and hand controls on the steering column enable precise maneuverability, making it suitable for individuals requiring powered mobility assistance.
How is the Soleus FAD-2 Powered Wheelchair powered and maintained?
The Soleus FAD-2 Powered Wheelchair operates using an onboard battery system, which provides the necessary power for mobility. It includes an onboard battery charger for convenience, allowing users to recharge the device without external equipment. Maintenance protocols determine whether the wheelchair is used as a single-use or reusable device, depending on the frequency of use and care. Regular cleaning and inspection are recommended to ensure optimal performance and safety.
Can the Soleus FAD-2 Powered Wheelchair be disassembled for transport?
Yes, the Soleus FAD-2 Powered Wheelchair is designed to be disassembled for transport. This feature makes it easier to move the device between locations, such as from a clinical setting to a home environment or during travel. Disassembly also simplifies storage when the wheelchair is not in use.
Is there any specific information regarding sterility or MRI safety for the Soleus FAD-2 Powered Wheelchair?
The provided data does not include specific details about sterility or MRI safety for the Soleus FAD-2 Powered Wheelchair. Users should consult manufacturer guidelines or additional documentation for any specific requirements related to these aspects, particularly in clinical settings where sterility may be a concern.
What regulatory approval does the Soleus FAD-2 Powered Wheelchair hold?
The Soleus FAD-2 Powered Wheelchair holds FDA clearance under the 510(k) classification, specifically under the regulation number 890.3860. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets the necessary safety and performance standards for powered wheelchairs.